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Eldecalcitol increases bone mineral density in Chinese osteoporotic patients without vitamin D or calcium supplementation

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Abstract

Eldecalcitol increased bone mineral density (BMD) and prevented vertebral fractures in vitamin D-sufficient osteoporotic subjects. However, the effect of eldecalcitol on BMD under vitamin D insufficiency is unknown. We examined the effect of eldecalcitol on BMD compared with alfacalcidol in osteoporotic patients without vitamin D or calcium supplementation. This is a randomized, double-blind, active comparator trial. 265 Chinese osteoporotic patients were randomly assigned to receive 0.75 μg eldecalcitol or 1.0 μg alfacalcidol for 12 months without vitamin D or calcium supplementation. Baseline calcium intakes were less than 550 mg/day and mean serum 25-hydroxyvitamin D [25(OH)D] was below 43 nmol/L in both groups. Baseline BMD tended to be lower in patients with lower calcium intake and serum 25(OH)D. Lumbar BMD increased by 2.05% higher in eldecalcitol than alfacalcidol group at 12 months. Total hip and femoral neck BMD also increased by 1.33 and 1.78%, respectively, in the eldecalcitol than the alfacalcidol group. The effect of eldecalcitol on BMD was not affected by serum 25(OH)D or calcium intake. The incidence of adverse events was not different between the two groups. Incidence of hypercalcemia in the edecalcitol group was not affected by serum 25(OH)D. In conclusion, baseline BMD tended to be lower in patients with low calcium intake and serum 25(OH)D. Eldecalcitol increased lumbar and hip BMD more than alfacalcidol regardless of serum 25(OH)D or calcium intake without vitamin D or calcium supplementation. These results suggest that eldecalcitol is effective in increasing the BMD of osteoporotic patients regardless of vitamin D status or calcium intake.

Clinical Trial Registration number JAPIC CTI 152904.

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Acknowledgements

The following investigators participated in the trial: Weibo Xia, Yan Jiang, Peking Union Medical College Hospital; Hai Tang, Beijing Friendship Hospital; Shuhui Guo, Beijing University First Hospital; Zhenlin Zhang, Shanghai 6th People’s Hospital; Qun Cheng, Shanghai Huadong Hospital affiliated to Fudan University; Hua Lin, Nanjing Drum Tower Hospital; Xiaolan Jin, Chengdu Military General Hospital; Wen Wu, Guangdong Province People’s Hospital; Li Wang, Tianjin Hospital; Mei Zhu, Tianjin Medical University General Hospital; Shi Bo, China–Japan Friendship Hospital; Jingbo Yu, Ningbo First Hospital; Yongjia Xu, Suzhou University Second Hospital; Yue Ding, Zhongshan University Sun-Yet-Sen Hospital; Ying Zhang, Guangzhou Medical University Third Hospital; Xiuzhen Zhang, Shanghai Tongji Hospital. The following investigators evaluated fractures in the trial: Wei Yu, Peking Union Medical College Hospital; Masako Ito, Nagasaki University. Toshitaka Nakamura, Touto Sangenjaya Rehabilitation Hospital, supported in developing the fracture evaluation procedures. Shuli He, Peking Union Medical College Hospital, provided support in developing the dietary calcium intake survey in the trial.

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Authors and Affiliations

  1. Department of Endocrinology, Peking Union Medical College Hospital, Beijing, China

    Yan Jiang & Weibo Xia

  2. Beijing Friendship Hospital Capital Medical University, Beijing, China

    Hai Tang

  3. Tianjin Hospital, Tianjin, China

    Xinlong Ma

  4. Huadong Hospital affiliated to Fudan University, Shanghai, China

    Qun Cheng

  5. Nanjing Drum Tower Hospital Affiliated of Nanjing University Medical School, Nanjing, China

    Hua Lin

  6. Chengdu Military General Hospital, Chengdu, China

    Xiaolan Jin

  7. Shanghai Sixth People Hospital, Shanghai, China

    Zhenlin Zhang

  8. Chugai Pharmaceutical Co., Ltd., Tokyo, Japan

    Tsuyoshi Kobayashi & Satomi Uehara

  9. Fujii Memorial Institute of Medical Sciences, Tokushima University, Tokushima, Japan

    Toshio Matsumoto

  10. Department of Radiology, Peking Union Medical College Hospital, Beijing, China

    Wei Yu

  11. Department of Nutrition, Peking Union Medical College Hospital, Beijing, China

    Shuli He

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  1. Yan Jiang
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  2. Hai Tang
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  3. Xinlong Ma
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Correspondence to Toshio Matsumoto or Weibo Xia.

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Conflict of interest

Weibo Xia serves as a consultant for Chugai Pharmaceutical Co., Ltd. Toshio Matsumoto serves as a consultant for Chugai Pharmaceutical Co., Ltd. and Amgen Inc. Tsuyoshi Kobayashi and Satomi Uehara are employees of Chugai Pharmaceutical Co., Ltd. Yan Jiang, Hai Tang, Xinlong Ma, Qun Cheng, Hua Lin, Xiaolan Jin, Zhenlin Zhang, Wei Yu, and Shuli He declare that they have no conflict of interest. This study was funded by Chugai Pharmaceutical Co., Ltd.

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Jiang, Y., Tang, H., Ma, X. et al. Eldecalcitol increases bone mineral density in Chinese osteoporotic patients without vitamin D or calcium supplementation. J Bone Miner Metab 37, 1036–1047 (2019). https://doi.org/10.1007/s00774-019-01009-9

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